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CFDA sets out principles for generic equivalency clinical trials

Follow up to last years’ release of new Bioequivalence guidelines

The China Food and Drug Administration (CFDA) this week released the latest guidance related to last year's new generic bioequivalence standards. As set out in the notification (No. 18), guidelines released last year established that in principle generic drugs should undergo in vivo bioequivalence to establish equivalency with originator drugs. This release is specifically designed to set out principles for companies that cannot find or determine a suitable reference preparation for such tests, and are therefore required to undergo clinical trials to establish their drug's efficacy.

The paper makes a detailed analysis of five aspects, including preliminary judgment of clinical efficacy, comparison drug, types of comparison, trial endpoints and patient enrollment numbers. Generic drugs undergoing clinical efficacy trials should be considered in terms of efficacy compared with other therapies, taking into account the presence or absence of other factors influencing the efficacy of existing therapies. The document encourages demonstration of superiority over a positive control drug. In addition, the document states that appropriate endpoint selection and patient enrollment targets can be determined with reference to existing guidelines for drug clinical trials. Please refer to the reference source for full details.